Advanced Medical Therapy and Cell Therapy are in worldwide expansion. However, deployment in some South & Central American locations often times encounters legal voids or a wrong ethical balance for the protection of research subjects versus the benefits of participation. We will succinctly address the components of present day Regulatory Guidelines in the US, Japan and Europe in contrast with the emerging efforts in Latin America. In a final expert panel we will discuss steps towards harmonization that might foster Multicentric International Clinical Trials and how LATAM Regulatory Panels can contribute to such coordination.
The Webinar is intended to provide 1) an overview of the scope of current Cell Therapies 2) a schema for the main components of the regulatory framework for ATMPs in the US, Japan and Europe, indicative of time-served pathways 3) A description of the more recent -2018- requirements established by the Brazilian Health Surveillance Agency for ATMP clinical trials. 4) a Panel discussion on steps that could contribute to the establishment of harmonized guidelines, enabling the development of research and Clinical trials of ATMPs in the South and Central American region.
Note: The LIVE event is Open Access however the recording is available to ISCT members only